Buchumschlag

Optimal designs for phase II/III drug development programs including methods for discounting of phase II results

Go/no-go decisions after phase II and sample size chosen for phase III are usually based on phase II results (e.g., the treatment effect estimate of phase II). Due to the decision rule (only promising phase II results lead to phase III), treatment effect estimates from phase II that initiate a phase...

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Bibliographische Detailangaben
Hauptverfasser: Erdmann, Stella (Verfasst von) , Kirchner, Marietta (Verfasst von) , Götte, Heiko (Verfasst von) , Kieser, Meinhard (Verfasst von)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: 09 October 2020
In: BMC medical research methodology
Year: 2020, Jahrgang: 20
ISSN:1471-2288
DOI:10.1186/s12874-020-01093-w
Online-Zugang:Verlag, kostenfrei, Volltext: https://doi.org/10.1186/s12874-020-01093-w
Volltext
Verfasserangaben:Stella Erdmann, Marietta Kirchner, Heiko Götte, Meinhard Kieser
Beschreibung
Zusammenfassung:Go/no-go decisions after phase II and sample size chosen for phase III are usually based on phase II results (e.g., the treatment effect estimate of phase II). Due to the decision rule (only promising phase II results lead to phase III), treatment effect estimates from phase II that initiate a phase III trial commonly overestimate the true treatment effect. Underpowered phase III trials are the consequence. Optimistic findings may then not be reproduced, leading to the failure of potentially expensive drug development programs. For some disease areas these failure rates are described to be quite high: 62.5%.
Beschreibung:Gesehen am 04.11.2020
Beschreibung:Online Resource
ISSN:1471-2288
DOI:10.1186/s12874-020-01093-w

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